AccessGUDID - DEVICE: DSQ Alert Candida auris Primer Mix ASR (03661540952531)

GUDID

Device Identifier (DI) Information

Brand Name: DSQ Alert Candida auris Primer Mix ASR
Version or Model: 800729
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 800729
Company Name: Elitechgroup Mdx LLC

Primary DI Number: 03661540952531
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117458512 *Terms of Use

Device Description: DSQ Alert™ Candida auris Primer Mix ASR is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify an 125 bp region within the ITS2 gene of Candida auris. The mix consists of a single vial containing a set of primers in a 1X TE buffer solution.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
64705	Assay development analyte-specific reagent IVD	An antibody, specific receptor protein, ligand, nucleic acid sequence (e.g., primer, probe) or similar reagent, which through specific binding or chemical reaction with an intended target, is used to identify or quantify a chemical substance in a biological specimen for the development of a laboratory developed test (LDT) or commercial in vitro diagnostic medical device (IVD). Commonly referred to as an analyte specific reagent (ASR), it is neither labelled with instructions for use nor diagnostic or performance claims.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MVU	Reagents, Specific, Analyte

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: less than -10 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c821d275-4299-4c44-9954-58f640477284
Public Version Date: December 20, 2022
Public Version Number: 1
DI Record Publish Date: December 12, 2022